Manufacturing Training Specialist

4 weeks ago

Philadelphia, United States Proclinical Staffing Full time

Manufacturing Training Specialist- Permanent- Philadelphia, PA

Proclinical is seeking a Manuf. Training Specialist to join our client's manufacturing team.

Primary Responsibilities:

The successful candidate will serve as a key trainer for the A-cell therapy manufacturing program. This role necessitates experience in aseptic gowning and techniques, cell culture, and ISO class 5 cleanroom operations.

Skills & Requirements:

  • Bachelor's degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture.
  • Technical knowledge of aseptic processing in cleanroom environments.
  • Knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning, and qualification.
  • Experience leading training, coaching/mentoring, learning initiatives.
  • Ability to mentor and provide best practices to new employees.
  • Ability to build relationships quickly and provide consistent, excellent support to staff.
  • Ability to accurately perform arithmetic calculations including decimals, percentages, and basic algebraic calculations.
  • Proactive, results-oriented, self-starter with strong leadership skills.
  • Ability to deal with ambiguity and manage constant change.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent presentation skills, both written and verbal.
  • Strong computer skills, problem-solving, and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES).
  • Working knowledge within a Learning Management System (LMS).
  • Proficiency in Microsoft (Excel, Word, Outlook)

Preferred Skills and Knowledge:

  • Experience with cell and gene therapy.
  • Experience with Master Control.

The Manufacturing Training Specialist responsibilities will be:

  • Develop a basic understanding of the current cell therapy manufacturing process and the equipment utilized.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Present and deliver content to manufacturing technicians.
  • Assist with the creation, review, and improvement of designated training scripts.
  • Support management with the alignment of manufacturing processes with technical training.
  • Help identify training needs and assist in establishing a feedback loop for continuous improvement.
  • Assist with drafting SOPs, Batch Records, Deviations, CAPAs, etc.
  • Appropriately escalate issues/concerns to Area Management for further investigation.
  • Troubleshoot unexpected results, prioritize workload, and solve moderately complex problems.
  • Work in a team environment or independently, as needed.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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